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Completed

NCT Number: NCT01892670

Storage Temperature and Quality of Leucoreduced Whole Blood

In a combat situation the need for safe and high-quality blood products is increasing. WB (Whole Blood) is used in many trauma situations, but we wish to investigate whether there is an even better whole blood product.

The purpose of this study is to examine the quality of leucoreduced, cold-stored whole blood. We also wish to examine the effects of filtration of whole blood without a 1-2 hour holding-time (warm-filtration) and the effects of forced filtration. We also wish to explore the possibility of using cold-stored WB for production of RCC.

Analyses are performed with a main focus to investigate function and quality of red blood cells and platelets.

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Key information

Conditions

Trauma Austere Environment Blood Bank Buddy Transfusion Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Dept of Immunology and Transfusion Medicine

Bergen, 5021, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteer
  • Age between 18 and 70
  • Negative pregnancy test (women in fertile age)
  • Blood pressure range: (160-100)/(100-40)
  • Pulse range: 40-100

Exclusion criteria

  • Usage of platelet-influencing medication
  • Mild flu or more severe illnesses
  • Open wound
  • Pregnancy or trying to get pregnant

Treatment and study plan

Donation of 1 whole blood unit

Other

Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.

Other names: Terumo IMUFLEX WB-SP collection bag system.

Primary outcomes

  1. Platelet function

    Time frame: After 10 days of cold-storage

    Platelet function is assessed by various parameters, such as thrombelastography (TEG), Multiplate and flow cytometry (Lactadherin, Calcein violet AM, ++).

Secondary outcomes

  1. Leukocyte count

    Time frame: After leukocyte filtration

    Filtered whole blood should have a concentration less than 1*10^6 cells/L to avoid transfusion reactions.

Other outcomes

  1. Hemolysis

    Time frame: After 42 days of storage

    RCC should not have a hemolysis of more than 0.8 %. We investigate this up to 42 days (35 days as RCC) (arm 5 +6)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Norwegian Armed Forces Medical Service

Registry information

Acronym: BFF

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 4, 2013
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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